• Merit Medical Reports Results for First Quarter March 31, 2023

    المصدر: Nasdaq GlobeNewswire / 26 أبريل 2023 16:05:01   America/New_York

    • Q1 2023 reported revenue of $297.6 million, up 8.0% compared to Q1 2022
    • Q1 2023 constant currency revenue, organic* up 9.8% compared to Q1 2022
    • Q1 2023 GAAP operating margin of 8.9%, compared to 5.5% in Q1 2022
    • Q1 2023 non-GAAP operating margin* of 16.1%, compared to 14.6% in Q1 2022
    • Q1 2023 GAAP EPS $0.36, compared to $0.18 in Q1 2022
    • Q1 2023 non-GAAP EPS* of $0.64, compared to $0.53 in Q1 2022

    *  Constant currency revenue; constant currency revenue, organic; non-GAAP EPS; non-GAAP net income; non-GAAP operating income and margin; non-GAAP gross profit and margin; and free cash flow are non-GAAP financial measures. A reconciliation of these financial measures to their most directly comparable GAAP financial measures is included under the heading “Non-GAAP Financial Measures” below.

    SOUTH JORDAN, Utah, April 26, 2023 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading global manufacturer and marketer of healthcare technology, today announced revenue of $297.6 million for the quarter ended March 31, 2023, an increase of 8.0% compared to the quarter ended March 31, 2022. Constant currency revenue, organic, for the first quarter of 2023 increased 9.8% compared to the prior year period.

    Merit’s revenue by operating segment and product category for the three-month periods ended March 31, 2023 and 2022 was as follows (unaudited; in thousands, except for percentages):

         Three Months Ended
      Reported     Constant Currency *
         March 31,     Impact of foreign March 31,    
         2023    2022 % Change exchange 2023 % Change
    Cardiovascular                      
    Peripheral Intervention $113,783  $105,773  7.6% $1,623  $115,406  9.1%
    Cardiac Intervention  85,328   81,487  4.7%  1,819   87,147  6.9%
    Custom Procedural Solutions  47,701   46,262  3.1%  1,243   48,944  5.8%
    OEM  41,164   33,414  23.2%  141   41,305  23.6%
    Total  287,976   266,936  7.9%  4,826   292,802  9.7%
                           
    Endoscopy                      
    Endoscopy Devices  9,589   8,479  13.1%  47   9,636  13.6%
                           
    Total $297,565  $275,415  8.0% $4,873  $302,438  9.8%


    Merit’s GAAP gross margin for the first quarter of 2023 was 46.5%, compared to GAAP gross margin of 43.9% for the prior year period. Merit’s non-GAAP gross margin* for the first quarter of 2023 was 50.1%, compared to non-GAAP gross margin of 47.7% for the prior year period.

    Merit’s GAAP net income for the first quarter of 2023 was $20.7 million, or $0.36 per share, compared to GAAP net income of $10.5 million, or $0.18 per share, for the first quarter of 2022. Merit’s non-GAAP net income* for the first quarter of 2023 was $37.5 million, or $0.64 per share, compared to non-GAAP net income of $30.4 million, or $0.53 per share, for the prior year period.

    “We delivered 9.8% constant currency revenue growth in the first quarter of 2023, exceeding the high-end of our expectations, driven primarily by better-than-expected growth in both the U.S. and international markets during the month of March,” said Fred P. Lampropoulos, Merit’s Chairman and Chief Executive Officer. “We also delivered significant year-over-year improvements in profitability with non-GAAP gross and operating margins of 50.1% and 16.1%, respectively, and more than 20% growth year-over-year in both non-GAAP net income and non-GAAP earnings per share.”

    Mr. Lampropoulos continued: “The impressive start to fiscal year 2023 is a direct result of our team’s continued focus on executing our multi-year strategic plan. We have updated our 2023 financial guidance to reflect the better-than-expected financial results in the first quarter and remain confident in our team’s ability to deliver continued progress in year three of our Foundations for Growth Program and the related financial targets for the three-year period ending December 31, 2023, which call for our constant currency, organic revenue to increase at a CAGR of at least 5%, non-GAAP operating margins of at least 18% and cumulative free cash flow of more than $300 million.”

    As of March 31, 2023, Merit had cash and cash equivalents of $57.9 million, total debt obligations of $197.8 million, and available borrowing capacity of approximately $521 million, compared to cash and cash equivalents of $58.4 million, total debt obligations of $198.2 million, and available borrowing capacity of approximately $523 million as of December 31, 2022.

    Updated Fiscal Year 2023 Financial Guidance
    Based upon the information currently available to Merit’s management, for the year ending December 31, 2023, absent material acquisitions, non-recurring transactions or other factors beyond Merit’s current expectations, Merit now expects the following:

    Revenue and Earnings Guidance*

         Updated Guidance As Reported   Prior Guidance
          % Change   
    Financial Measure December 31, 2023 December 31, 2022 from Prior Year December 31, 2023
             
    Net Sales $1.217 - $1.229 billion $1.151 billion 6% - 7% $1.194 - $1.210 billion
    Cardiovascular Segment $1.179 - $1.191 billion $1.118 billion 5% - 6% $1.156 - $1.172 billion
    Endoscopy Segment $37.8 - $38.1 million $32.8 million 15% - 16% $37.5 - $37.8 million
             
    GAAP           
    Net Income $100 - $105 million $74.5 million   $100 - $105 million
    Earnings Per Share $1.71 - $1.79 $1.29   $1.72 - $1.80
             
    Non-GAAP           
    Net Income $166 - $171 million $155.8 million   $163 - $168 million
    Earnings Per Share $2.83 - $2.93 $2.70   $2.80 - $2.89

    *Percentage figures approximated; dollar figures may not foot due to rounding

    2023 Net Sales Guidance - % Change from Prior Year (Constant Currency) Reconciliation*

      Updated Guidance Prior Guidance
      Low High Low High
    2023 Net Sales Guidance - % Change from Prior Year (GAAP) 5.7% 6.8% 4.0% 5.0%
    Estimated impact of foreign currency exchange rate fluctuations -0.4% -0.3% -1.0% -1.0%
    2023 Net Sales Guidance - % Change from Prior Year (Constant Currency) 6.1% 7.1% 5.0% 6.0%

    *Percentage figures approximated; dollar figures may not foot due to rounding

    Merit’s financial guidance for the year ending December 31, 2023 is subject to risks and uncertainties identified in this release and Merit’s filings with the U.S. Securities and Exchange Commission (the “SEC”).

    CONFERENCE CALL
    Merit will hold its investor conference call today, Wednesday, April 26, 2023, at 5:00 p.m. Eastern (4:00 p.m. Central, 3:00 p.m. Mountain, and 2:00 p.m. Pacific). To access the conference call, please pre-register using the following link. Registrants will receive confirmation with dial-in details. A live webcast and slide deck will also be available at merit.com.


    CONSOLIDATED BALANCE SHEETS
    (in thousands)
     
         March 31,       
      2023
     December 31, 
      (Unaudited) 2022
    ASSETS      
    Current Assets      
    Cash and cash equivalents $57,945  $58,408 
    Trade receivables, net  170,182   164,677 
    Other receivables  14,559   12,992 
    Inventories  289,581   265,991 
    Prepaid expenses and other assets  19,961   22,324 
    Prepaid income taxes  3,920   3,913 
    Income tax refund receivables  1,069   779 
    Total current assets  557,217   529,084 
           
    Property and equipment, net  387,450   382,976 
    Intangible assets, net  263,884   275,872 
    Goodwill  360,291   359,821 
    Deferred income tax assets  6,665   6,599 
    Operating lease right-of-use assets  62,881   65,262 
    Other assets  45,721   44,352 
    Total Assets $1,684,109  $1,663,966 
           
    LIABILITIES AND STOCKHOLDERS' EQUITY      
    Current Liabilities      
    Trade payables $65,588  $68,504 
    Accrued expenses  119,197   123,189 
    Current portion of long-term debt  11,250   11,250 
    Current operating lease liabilities  10,898   11,005 
    Income taxes payable  9,019   6,697 
    Total current liabilities  215,952   220,645 
           
    Long-term debt  186,423   186,759 
    Deferred income tax liabilities  18,478   18,462 
    Long-term income taxes payable  347   347 
    Liabilities related to unrecognized tax benefits  1,912   1,912 
    Deferred compensation payable  15,868   15,264 
    Deferred credits  1,682   1,708 
    Long-term operating lease liabilities  57,893   59,736 
    Other long-term obligations  13,899   14,736 
    Total liabilities  512,454   519,569 
           
    Stockholders' Equity      
    Common stock  681,108   675,174 
    Retained earnings  501,476   480,773 
    Accumulated other comprehensive loss  (10,929)  (11,550)
    Total stockholders' equity  1,171,655   1,144,397 
    Total Liabilities and Stockholders' Equity $1,684,109  $1,663,966 



    CONSOLIDATED STATEMENTS OF INCOME
    (Unaudited; in thousands except per share amounts)
         Three Months Ended
      March 31, 
         2023    2022
    Net sales $297,565  $275,415 
    Cost of sales  159,203   154,508 
    Gross profit  138,362   120,907 
           
    Operating expenses:      
    Selling, general and administrative  90,144   84,015 
    Research and development  21,314   17,387 
    Impairment charges     1,672 
    Contingent consideration expense  521   2,600 
    Total operating expenses  111,979   105,674 
           
    Income from operations  26,383   15,233 
           
    Other income (expense):      
    Interest income  131   104 
    Interest expense  (2,011)  (1,002)
    Other income (expense) — net  997   (164)
    Total other expense — net  (883)  (1,062)
           
    Income before income taxes  25,500   14,171 
           
    Income tax expense  4,797   3,626 
           
    Net income $20,703  $10,545 
           
    Earnings per common share      
    Basic $0.36  $0.19 
    Diluted $0.36  $0.18 
           
    Weighted average shares outstanding      
    Basic  57,352   56,593 
    Diluted  58,183   57,531 



    CONSOLIDATED STATEMENTS OF CASH FLOWS
    (In thousands - unaudited)
      Three Months Ended
      March 31, 
         2023    2022
    CASH FLOWS FROM OPERATING ACTIVITIES:    
    Net income $20,703  $10,545 
    Adjustments to reconcile net income to net cash provided by operating activities:      
    Depreciation and amortization  20,537   20,466 
    Write-off of certain intangible assets and other long-term assets     1,672 
    Amortization of right-of-use operating lease assets  2,662   2,584 
    Adjustments related to contingent consideration liabilities  521   2,600 
    Stock-based compensation expense  3,969   4,642 
    Other adjustments  332   218 
    Changes in operating assets and liabilities, net of acquisitions and divestitures  (34,179)  (30,717)
    Total adjustments  (6,158)  1,465 
    Net cash, cash equivalents, and restricted cash provided by operating activities  14,545   12,010 
           
    CASH FLOWS FROM INVESTING ACTIVITIES:      
    Capital expenditures for property and equipment  (12,785)  (9,526)
    Cash paid in acquisitions, net of cash acquired  (2,000)   
    Other investing, net  (71)  (342)
    Net cash, cash equivalents, and restricted cash used in investing activities  (14,856)  (9,868)
           
    CASH FLOWS FROM FINANCING ACTIVITIES:    
    Proceeds from issuance of common stock  4,028   1,641 
    (Payments on) proceeds from issuance of long-term debt  (365)  9,625 
    Contingent payments related to acquisitions  (2,568)  (24,491)
    Payment of taxes related to an exchange of common stock  (1,592)  (1,015)
    Net cash, cash equivalents, and restricted cash used in financing activities  (497)  (14,240)
    Effect of exchange rates on cash  376   111 
    Net increase in cash, cash equivalents and restricted cash  (432)  (11,987)
           
    CASH, CASH EQUIVALENTS AND RESTRICTED CASH:      
    Beginning of period  60,558   67,750 
    End of period $60,126  $55,763 
           
    RECONCILIATION OF CASH, CASH EQUIVALENTS AND RESTRICTED CASH TO THE CONSOLIDATED BALANCE SHEETS:      
    Cash and cash equivalents  57,945   53,875 
    Restricted cash reported in prepaid expenses and other current assets  2,181   1,888 
    Total cash, cash equivalents and restricted cash $60,126  $55,763 


    Non-GAAP Financial Measures
    Although Merit’s financial statements are prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”), Merit’s management believes that the non-GAAP financial measures referenced in this release provide investors with useful information regarding the underlying business trends and performance of Merit’s ongoing operations and can be useful for period-over-period comparisons of such operations. Non-GAAP financial measures used in this release include:

    • constant currency revenue;
    • constant currency revenue, organic;
    • non-GAAP gross profit and margin;
    • non-GAAP operating income and margin;
    • non-GAAP net income;
    • non-GAAP earnings per share; and
    • free cash flow.

    Merit’s management team uses these non-GAAP financial measures to evaluate Merit’s profitability and efficiency, to compare operating and financial results to prior periods, to evaluate changes in the results of its operating segments, and to measure and allocate financial resources internally. However, Merit’s management does not consider such non-GAAP measures in isolation or as an alternative to measures determined in accordance with GAAP.

    Readers should consider non-GAAP measures used in this release in addition to, not as a substitute for, financial reporting measures prepared in accordance with GAAP. These non-GAAP financial measures generally exclude some, but not all, items that may affect Merit’s net income. In addition, they are subject to inherent limitations as they reflect the exercise of judgment by management about which items are excluded. Merit believes it is useful to exclude such items in the calculation of non-GAAP earnings per share, non-GAAP gross profit and margin, non-GAAP operating income and margin, and non-GAAP net income (in each case, as further illustrated in the reconciliation tables below) because such amounts in any specific period may not directly correlate to the underlying performance of Merit’s business operations and can vary significantly between periods as a result of factors such as acquisition or other extraordinary transactions, non-cash expenses related to amortization or write-off of previously acquired tangible and intangible assets, certain severance expenses, expenses resulting from non-ordinary course litigation or administrative proceedings and resulting settlements, corporate transformation expenses, governmental proceedings or changes in tax or industry regulations, gains or losses on disposal of certain assets, and debt issuance costs. Merit may incur similar types of expenses in the future, and the non-GAAP financial information included in this release should not be viewed as a statement or indication that these types of expenses will not recur. Additionally, the non-GAAP financial measures used in this release may not be comparable with similarly titled measures of other companies. Merit urges readers to review the reconciliations of its non-GAAP financial measures to their most directly comparable GAAP financial measures, and not to rely on any single financial measure to evaluate Merit’s business or results of operations.

    Constant Currency Revenue

    Merit’s constant currency revenue is prepared by converting the current-period reported revenue of subsidiaries whose functional currency is a currency other than the U.S. dollar at the applicable foreign exchange rates in effect during the comparable prior-year period and adjusting for the effects of hedging transactions on reported revenue, which are recorded in the U.S. dollar. The constant currency revenue adjustment of $4.9 million to reported revenue for the three-month period ended March 31, 2023 was calculated using the applicable average foreign exchange rates for the three-month period ended March 31, 2022.

    Constant Currency Revenue, Organic

    Merit’s constant currency revenue, organic, is defined, with respect to prior fiscal year periods, as GAAP revenue. With respect to current fiscal year periods, constant currency revenue, organic, is defined as constant currency revenue (as defined above), less revenue from certain acquisitions. For the three-month period ended March 31, 2023, there were no revenues from acquisitions excluded in the calculation of Merit’s constant currency revenue, organic.

    Non-GAAP Gross Profit and Margin

    Non-GAAP gross profit is calculated by reducing GAAP cost of sales by amounts recorded for amortization of intangible assets. Non-GAAP gross margin is calculated by dividing non-GAAP gross profit by reported net sales.

    Non-GAAP Operating Income and Margin

    Non-GAAP operating income is calculated by adjusting GAAP operating income for certain items which are deemed by Merit’s management to be outside of core operations and vary in amount and frequency among periods, such as expenses related to acquisitions or other extraordinary transactions, non-cash expenses related to amortization or write-off of previously acquired tangible and intangible assets, certain severance expenses, performance-based stock compensation expenses, corporate transformation expenses, expenses resulting from non-ordinary course litigation or administrative proceedings and resulting settlements, governmental proceedings, and changes in governmental or industry regulations, as well as other items referenced in the tables below. Non-GAAP operating margin is calculated by dividing non-GAAP operating income by reported net sales.

    Non-GAAP Net Income

    Non-GAAP net income is calculated by adjusting GAAP net income for the items set forth in the definition of non-GAAP operating income above, as well as for expenses related to debt issuance costs, gains or losses on disposal of certain assets, changes in tax regulations, and other items set forth in the tables below.

    Non-GAAP EPS

    Non-GAAP EPS is defined as non-GAAP net income divided by the diluted shares outstanding for the corresponding period.

    Free Cash Flow

    Free cash flow is defined as cash flow from operations calculated in accordance with GAAP, less capital expenditures for property and equipment calculated in accordance with GAAP, as set forth in the consolidated statement of cash flows.

    Non-GAAP Financial Measure Reconciliations

    The following tables set forth supplemental financial data and corresponding reconciliations of non-GAAP financial measures to Merit’s corresponding financial measures prepared in accordance with GAAP, in each case, for the three-month periods ended March 31, 2023 and 2022. The non-GAAP income adjustments referenced in the following tables do not reflect non-performance-based stock compensation expense of approximately $2.7 million and $3.4 million for the three-month periods ended March 31, 2023 and 2022, respectively.


    Reconciliation of GAAP Net Income to Non-GAAP Net Income
    (Unaudited; in thousands except per share amounts)

      Three Months Ended
      March 31, 2023
      Pre-Tax Tax Impact After-Tax Per Share Impact
    GAAP net income $25,500  $(4,797) $20,703  $0.36 
                    
    Non-GAAP adjustments:               
    Cost of Sales               
    Amortization of intangibles  10,616   (2,553)  8,063   0.14 
    Operating Expenses               
    Contingent consideration expense  521   (45)  476   0.01 
    Amortization of intangibles  1,665   (402)  1,263   0.02 
    Performance-based share-based compensation (a)  1,287   (87)  1,200   0.02 
    Corporate transformation and restructuring (b)  3,546   (851)  2,695   0.05 
    Acquisition-related  255   (61)  194   0.00 
    Medical Device Regulation expenses (c)  3,658   (878)  2,780   0.05 
    Other (d)  34   (8)  26   0.00 
    Other (Income) Expense               
    Amortization of long-term debt issuance costs  151   (36)  115   0.00 
                    
    Non-GAAP net income $47,233  $(9,718) $37,515  $0.64 
                    
    Diluted shares             58,183 


      Three Months Ended
      March 31, 2022
      Pre-Tax Tax Impact After-Tax Per Share Impact
    GAAP net income $14,171  $(3,626) $10,545  $0.18 
                    
    Non-GAAP adjustments:               
    Cost of Sales               
    Amortization of intangibles  10,552   (2,587)  7,965   0.14 
    Operating Expenses               
    Contingent consideration expense  2,600   (8)  2,592   0.05 
    Impairment charges  1,672   (318)  1,354   0.02 
    Amortization of intangibles  1,607   (398)  1,209   0.02 
    Performance-based share-based compensation (a)  1,245   (124)  1,121   0.02 
    Corporate transformation and restructuring (b)  5,077   (1,243)  3,834   0.07 
    Acquisition-related  228   (55)  173   0.00 
    Medical Device Regulation expenses (c)  1,919   (470)  1,449   0.03 
    Other (d)  85   (21)  64   0.00 
    Other (Income) Expense               
    Amortization of long-term debt issuance costs  151   (37)  114   0.00 
                    
    Non-GAAP net income $39,307  $(8,887) $30,420  $0.53 
                    
    Diluted shares             57,531 

    ________________________
    Note: Certain per share impacts may not sum to totals due to rounding.


    Reconciliation of Reported Operating Income to Non-GAAP Operating Income
    (Unaudited; in thousands except percentages)

      Three Months Ended Three Months Ended
      March 31, 2023 March 31, 2022
      Amounts % Sales Amounts % Sales
    Net Sales as Reported $297,565     $275,415    
                   
    GAAP Operating Income  26,383  8.9%  15,233  5.5%
    Cost of Sales              
    Amortization of intangibles  10,616  3.6%  10,552  3.8%
    Operating Expenses              
    Contingent consideration expense  521  0.2%  2,600  0.9%
    Impairment charges       1,672  0.6%
    Amortization of intangibles  1,665  0.6%  1,607  0.6%
    Performance-based share-based compensation (a)  1,287  0.4%  1,245  0.5%
    Corporate transformation and restructuring (b)  3,546  1.2%  5,077  1.8%
    Acquisition-related  255  0.1%  228  0.1%
    Medical Device Regulation expenses (c)  3,658  1.2%  1,919  0.7%
    Other (d)  34  0.0%  85  0.0%
                   
    Non-GAAP Operating Income $47,965  16.1% $40,218  14.6%

    ________________________
    Note: Certain percentages may not sum to totals due to rounding

    a)   Represents performance-based share-based compensation expense, including stock-settled and cash-settled awards.
    b)   Includes consulting expenses related to the Foundations for Growth Program and other transformation costs, including severance related to corporate initiatives.
    c)   Represents incremental expenses incurred to comply with the E.U. Medical Device Regulation (“MDR”).
    d)   Represents costs to comply with Merit’s corporate integrity agreement with the U.S. Department of Justice (the “DOJ”).


    Reconciliation of Reported Revenue to Constant Currency Revenue (Non-GAAP), and Constant Currency Revenue, Organic (Non-GAAP)
    (Unaudited; in thousands except percentages)

               
        Three Months Ended
        March 31,
      % Change 2023 2022
    Reported Revenue 8.0%$297,565  $275,415 
               
    Add: Impact of foreign exchange    4,873    
               
    Constant Currency Revenue (a) 9.8%$302,438  $275,415 
               
    Less: Revenue from certain acquisitions        
               
    Constant Currency Revenue, Organic (a) 9.8%$302,438  $275,415 

    ________________________
    (a)   A non-GAAP financial measure. For a definition of this and other non-GAAP financial measures, see the section of this release entitled “Non-GAAP Financial Measures.”


    Reconciliation of Reported Gross Margin to Non-GAAP Gross Margin (Non-GAAP)
    (Unaudited; as a percentage of reported revenue)

           
      Three Months Ended 
      March 31, 
      2023  2022 
    Reported Gross Margin 46.5% 43.9%
           
    Add back impact of:      
    Amortization of intangibles 3.6% 3.8%
           
    Non-GAAP Gross Margin 50.1% 47.7%

    ________________________
    Note: Certain percentages may not sum to totals due to rounding


    ABOUT MERIT
    Founded in 1987, Merit Medical Systems, Inc. is a leading global manufacturer and marketer of healthcare technology. Merit serves client hospitals worldwide with a domestic and international sales force and clinical support team totaling in excess of 700 individuals. Merit employs approximately 7,100 people worldwide with facilities in South Jordan, Utah; Pearland, Texas; Richmond, Virginia; Aliso Viejo, California; Maastricht and Venlo, The Netherlands; Paris, France; Galway, Ireland; Beijing, China; Tijuana, Mexico; Joinville, Brazil; Ontario, Canada; Melbourne, Australia; Tokyo, Japan; Reading, United Kingdom; Johannesburg, South Africa; and Singapore.

    CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
    Statements contained in this release which are not purely historical, including, without limitation, statements regarding Merit’s forecasted plans, revenues, net sales, net income (GAAP and non-GAAP), operating income and margin (GAAP and non-GAAP), gross profit and margin (GAAP and non-GAAP), earnings per share (GAAP and non-GAAP), free cash flow, and other financial measures, future growth and profit expectations or forecasted economic conditions, or the implementation of, and results which may be achieved through, Merit’s Foundations for Growth Program or other expense reduction initiatives, are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and are subject to risks and uncertainties such as those described in Merit’s Annual Report on Form 10-K for the year ended December 31, 2022 (the “2022 Annual Report”) and other filings with the SEC. Such risks and uncertainties include inherent risks and uncertainties relating to Merit’s internal models or the projections in this release; disruptions in Merit’s supply chain, manufacturing or sterilization processes; reduced availability of, and price increases associated with, commodity components and other raw materials; adverse changes in freight, shipping and transportation expenses; negative changes in economic and industry conditions in the United States or other countries, including inflation; risks relating to Merit’s potential inability to successfully manage growth through acquisitions generally, including the inability to effectively integrate acquired operations or products or commercialize technology developed internally or acquired through completed, proposed or future transactions; risks associated with Merit’s ongoing or prospective manufacturing transfers and facility consolidations; fluctuations in interest or foreign currency exchange rates; risks and uncertainties associated with Merit’s information technology systems, including the potential for breaches of security and evolving regulations regarding privacy and data protection; governmental scrutiny and regulation of the medical device industry, including governmental inquiries, investigations and proceedings involving Merit; consequences associated with a Corporate Integrity Agreement executed between Merit and the U.S. Office of Inspector General; difficulties, delays and expenditures relating to development, testing and regulatory approval or clearance of Merit’s products, including the pursuit of approvals under the MDR, and risks that such products may not be developed successfully or approved for commercial use; litigation and other judicial proceedings affecting Merit; the potential of fines, penalties or other adverse consequences if Merit’s employees or agents violate the U.S. Foreign Corrupt Practices Act or other laws or regulations; restrictions on Merit’s liquidity or business operations resulting from its debt agreements; infringement of Merit’s technology or the assertion that Merit’s technology infringes the rights of other parties; product recalls and product liability claims; changes in customer purchasing patterns or the mix of products Merit sells; laws and regulations targeting fraud and abuse in the healthcare industry; potential for significant adverse changes in governing regulations, including reforms to the procedures for approval or clearance of Merit’s products by the U.S. Food & Drug Administration or comparable regulatory authorities in other jurisdictions; changes in tax laws and regulations in the United States or other jurisdictions; termination of relationships with Merit’s suppliers, or failure of such suppliers to perform; concentration of a substantial portion of Merit’s revenues among a few products and procedures; development of new products and technology that could render Merit’s existing or future products obsolete; market acceptance of new products; dependance on distributors to commercialize Merit’s products in various jurisdictions outside the United States; volatility in the market price of Merit’s common stock; modification or limitation of governmental or private insurance reimbursement policies; changes in healthcare policies or markets related to healthcare reform initiatives; failure to comply with applicable environmental laws; changes in key personnel; work stoppage or transportation risks; failure to introduce products in a timely fashion; price and product competition; fluctuations in and obsolescence of inventory; and risks and uncertainties associated with the COVID-19 pandemic and Merit’s response thereto; and other factors referenced in the 2022 Annual Report and other materials filed with the SEC. All subsequent forward-looking statements attributable to Merit or persons acting on its behalf are expressly qualified in their entirety by these cautionary statements. Actual results will likely differ, and may differ materially, from anticipated results. Financial estimates are subject to change and are not intended to be relied upon as predictions of future operating results. Those estimates and all other forward-looking statements included in this document are made only as of the date of this document, and except as otherwise required by applicable law, Merit assumes no obligation to update or disclose revisions to estimates and all other forward-looking statements.

    TRADEMARKS
    Unless noted otherwise, trademarks and registered trademarks used in this release are the property of Merit Medical Systems, Inc. and its subsidiaries in the United States and other jurisdictions.

      
    Contacts:
     
      
    PR/Media Inquiries:
    Teresa Johnson
    Merit Medical
    Investor Inquiries:
    Mike Piccinino, CFA, IRC
    Westwicke - ICR
    +1-801-208-4295+1-443-213-0509
    tjohnson@merit.commike.piccinino@westwicke.com
      


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